Regulatory Focus™ > News Articles > 2019 > 10 > Recon: J&J Hit With $8B Damages in Risperdal Suit; FDA Approves Clinuvel’s Genetic Skin Disorder Dru

Recon: J&J Hit With $8B Damages in Risperdal Suit; FDA Approves Clinuvel’s Genetic Skin Disorder Drug

Posted 09 October 2019 | By Michael Mezher 

Recon: J&J Hit With $8B Damages in Risperdal Suit; FDA Approves Clinuvel’s Genetic Skin Disorder Drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • J&J Hit With $8 Billion Jury Award Over Antipsychotic Drug (WSJ) (Reuters)
  • FDA approves Clinuvel's rare genetic disorder treatment, shares at record high (Reuters) (FDA)
  • Trump to Sign Order Reining in ‘Rogue Agencies’ Rulemaking (Bloomberg)
  • Cracks in Purdue's proposed opioid settlement as Arizona backs out (Reuters) (Law360-$)
  • 2020 Democrats embrace aggressive step on drug prices (The Hill)
  • Illumina confronts the innovator’s dilemma (STAT)
  • The return of Vioxx: Can a drug once deemed deadly be relaunched to treat rare disease? (STAT)
In Focus: International
  • The new top 20 pharma list: Takeda jumps on, Biogen pushed out — and more big changes are on the way (Endpoints)
  • GSK recalls popular heartburn drug Zantac globally after cancer scare (Reuters) (The Guardian)
  • Swedish hospital sounds all clear after testing patient for Ebola (Reuters) (NBC)
  • Novo taps bluebird bio for gene-editing tech (Fierce)
  • Merck seeks partner for disease-modifying osteoarthritis drug (PMLive)
  • Scotland’s SMC OKs Drugs For Cancer & Plaque Psoriasis (Pink Sheet-$)
  • Bayer forms drug discovery pact with Japan's Riken Innovation (Fierce) (Press)
  • Another one of Neil Woodford's portfolio companies escapes as UK biotech execs flee (Endpoints)
Pharmaceuticals & Biotechnology
  • Pharma, Biotech VC Investments Continue Shift to Early Stage Deals (Xconomy)
  • Five Years After Y Combinator First Admits Biotechs, They’re Dug In (Xconomy)
  • Partner Bayer pushes Ionis' antithrombotic drug into mid-stage development (Endpoints)
  • Pregnant Women Should Get Flu and Whooping Cough Shots, CDC Says (NYTimes)
  • Sexually Transmitted Disease Cases Rise to Record High, CDC Says (NYTimes)
  • BioMarin puts Lon Cardon in charge of portfolio strategy while gene therapy filings get underway (Endpoints)
  • Theragnostics, GE Healthcare announce prostate cancer diagnostic partnership (PharmaTimes) (MassDevice)
  • Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent (Pink Sheet-$)
  • GSK partners with Lyell Immunopharma to develop cell therapies for cancer (Pharmafile)
  • Novartis' ligelizumab outperforms Roche's Xolair in chronic urticaria clearance (Pharmafile)
  • A new player is taking the field in a push for a hemophilia A gene therapy, and it’s a big one (Endpoints)
  • FDA Issues Draft Guidance on Expanded Conditional Approval for Animal Drugs (FDA Law Blog)
  • Prolific Insilico scores up to $200M deal in China; Researchers retract paper on gene involved in CRISPR baby controversy (Endpoints)
  • A small biotech raises the price on its cancer drug by 20% this year, but will anyone notice? (STAT)
  • ICER’s concern for patients: Where’s the beef? (STAT)
  • Audentes' Gene Therapy Allows Ventilator Independence For Rare Disease (Scrip-$)
  • Innovative treatment Cablivi (caplacizumab-yhdp) granted new technology payment (NTAP) for Medicare payment (Press)
  • Economic Impacts of the California Institute for Regenerative Medicine (CIRM) (Report)
  • ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FDA approves Pfenex's osteoarthritis drug for patients at high risk of fracture (Pharmafile)
  • Shionogi celebrates antibiotic win in pneumonia just ahead of its date with FDA regulators (Endpoints) (Press)
  • FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients (Press)
  • Dermira Announces Initiation of Phase 3 Program Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis (Press)
  • Galderma Announces Positive Phase 2 Results for its Proprietary Liquid Formulation of an Investigational Botulinum Toxin and Approval of New State-of-the-Art Manufacturing Facility (Press)
  • Annexon Biosciences Reports Top-line Phase 1b Results for Novel C1q Inhibitor ANX007 in Glaucoma (Press)
  • Stuck with a PhIII gene therapy failure at 96 weeks, GenSight prefers the upbeat assessment (Endpoints)
  • VirTrial Awarded FDA-Approved Decentralized Clinical Trial with Hope Biosciences (Press)
Medical Devices
  • Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue (FDA)
  • Dexcom G6 Pro CGM gets FDA nod (Mobihealthnews)
  • Qiagen and Illumina in It for the Long Haul with 15-year Collaboration (MDDI)
  • Medtronic and Axonics Go Toe-to-Toe in Fast-Growing Sacral Neuromodulation Market (MDDI)
  • Corvia Medical's Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure (Press)
  • BioCardia wins CE Mark renewal for Helix, Morph catheters (MassDevice)
  • Mobidiag Gets CE Mark for Intestinal Parasites Test (GenomeWeb)
  • Study: Abbott, Edwards may have mislabeled hundreds of patient deaths (MassDevice)
US: Assorted & Government
  • Medicare Fraudsters Now Tap Telemedicine In Medical Equipment Scams (KHN)
  • Questions Swirl Around Opioid MDL Bellwether Trial (Law360-$)
  • Amid next-gen vaccine race, Merck says ex-employee bolted to Pfizer with 'thousands' of key documents (Fierce)
  • Purdue's Sackler Family Loses Bid To Toss Mass. Opioid Suit (Law360-$)
  • Purdue Agrees To Put Off Consideration Of Ch. 11 Bonuses (Law360-$)
  • Insys Seeks Extension Of Ch. 11 Plan Exclusivity Period (Law360-$)
  • Ex-Biomet worker in Brazilian bribery case loses appeal in defamation suit (MassDevice)
  • PixarBio CEO's Greed Drove Stock Fraud, Boston Jury Hears (Law360-$)
  • Pharmacists in Maryland Owe No Duty of Informed Consent (Drug & Device Law)
  • OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019) (Patent Docs)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States – 18-19 November 2019
  • Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features – 29 November 2019
  • Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives; Public Workshop – 12 November 2019
  • PMDA-ATC Pharmacovigilance Seminar 2020 – 3-6 February 2020
Europe
  • MHRA Portal: register to submit forms (MHRA)
  • Medical devices: UK notified bodies (MHRA)
  • Good manufacturing practice and good distribution practice (MHRA)
  • Guidance on pharmacovigilance procedures in the event of a no-deal Brexit (MHRA)
  • Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check (MHRA)
  • Completed Paediatric Studies - submission, processing and assessment in a no-deal Brexit (MHRA)
  • Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes (MHRA)
  • Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035) (MHRA)
  • Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034) (MHRA)
India
  • CDSCO notifies four medical devices testing labs in the country to ensure quality (Pharmabiz)
  • Govt assures regulation of all medical devices in a stipulated time frame (Pharmabiz)
  • NHSRC re-designated as WHO collaborating centre for priority medical devices and health technology policy (Pharmabiz)
Australia
  • Guidelines for using the TGA assessed claim on medicine labels (TGA)
  • Targeted consultation: Review of chemical scheduling in relation to cosmetic and fragrance ingredients (TGA)
  • Importation of e-cigarettes containing nicotine (and nicotine-containing liquids for use in e-cigarettes) (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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